Psychological Impact of Pregnancy of Unknown Location

Imperial College London150 enrolled

Overview

To assess the psychological impact of pregnancy of unknown location (PUL) classification pending a final diagnosis.

PUL is a syndrome of early pregnancy composed of a positive urine pregnancy test without the visualisation of a pregnancy on trans-vaginal ultrasound (TVUS). The current method for risk stratifying a PUL is via serum BhCG levels at the time of identification of PUL and after 48 hours, in order to ascertain the viability of the pregnancy. Patients and their partners need to wait for this result before a management plan can be adopted, taking at least 2-3 hours. There is a clear need for the patient care pathway to evolve in order to aid and improve the management of women classified with a PUL. By using point-of-care BhCG testing, the investigators hope to shorten the time to management. The investigators therefore propose that shortening the time interval would reduce psychological morbidity. This is a prospective cohort observational study.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Pregnancy of Unknown Location Ectopic Pregnancy Anxiety

Interventions

The Hospital and Anxiety Depression ScaleOTHER

Patients and partners will be asked to complete the questionnaire at three time points: 1) On classification of PUL at time zero once blood is taken, 2) at the 48-hour time point after blood is taken (if 48 hour bloods are required for the patient); and 3) after definitive diagnosis and management.

Point of care testing (POCT)OTHER

Patients will have 1ml sample of blood taken for POCT at two time points: 1) On classification of PUL at time zero at the same time as when routine blood samples taken; and 2) at the 48-hour time point at the same time as when routine blood samples are taken (if 48 hour bloods are required).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women attending the Early Pregnancy Unit in the first trimester (up to 14 weeks gestation) with a pregnancy of unknown who are over 18 years old and are able to give consent. Exclusion Criteria: * Presence diagnosed with cancer * The presence of an acute medical condition * Patients/partners aged less than 18 years * Patients or partners who cannot give fully informed study consent (language or learning impairment) * Presence of a viable intrauterine pregnancy, ectopic pregnancy and miscarriage.

Locations (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

Psychological Morbidity

Psychological morbidity will be assessed using the Hospital Anxiety and Depression Scale on time of PUL classification, 48 hours from PUL classification and following final diagnosis and management. For both Anxiety and Depression, participants can score anywhere from 0 to 21. Score of 11 and above indicate moderate to severe anxiety and depression.

Time frame: 0 hours, 48 hours and point of diagnosis (within 2 wees)

Data from ClinicalTrials.gov

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